federal_register: 2012-29157

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document_number title type abstract publication_date pub_year pub_month html_url pdf_url agency_names agency_ids excerpts regulation_id_numbers
2012-29157 Guidance on Food and Drug Administration Oversight of Positron Emission Tomography Drug Products-Questions and Answers; Availability Notice The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled "FDA Oversight of PET Drug Products--Questions and Answers." This guidance provides questions and answers that address nearly all aspects of the FDA approval and surveillance processes, including application submission, review, compliance with good manufacturing practices, inspections, registration and listing, and user fees. 2012-12-04 2012 12 https://www.federalregister.gov/documents/2012/12/04/2012-29157/guidance-on-food-and-drug-administration-oversight-of-positron-emission-tomography-drug https://www.govinfo.gov/content/pkg/FR-2012-12-04/pdf/2012-29157.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled "FDA Oversight of PET Drug Products--Questions and Answers." This guidance provides questions and answers that address nearly all aspects of the FDA approval...  

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